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Full notification Final report - General information Notification Number B/ES/22/18 Member State to which the notification was sent Spain Date of acknowledgement from the Member State Competent Authority 10/06/2022 Title of the Project “A Phase IIb, Open-label, Randomized Study of Nab-Paclitaxel and Gemcitabine plus/minus VCN01 in Patients with Metastatic Pancreatic Canc Proposed period of release: 01/10/2022 to 30/04/2024 Name of the Institute(s) or Company(ies) VCN Biosciences S.L., BioIncubadora I. Biopol’H BioPol'H Av Gran Via de l'Hospitalet 199‐203 08908 ‐ L'Hospitalet de Llobregat (Barcelona, SPAIN)
Is the same GMO been notified elsewhere by the same notifier? Yes:
Germany;
Has the same GMO been notified elsewhere by the same notifier? Yes If yes, notification number(s): B/ES/13/05, B/ES/13/04; GMO characterization GMO is a: DNA Virus Identity of the GMO: Order: Adenoviriae Genus: Mastadenovirus Species: Human Adenovirus serotype 5 (HAd5) The GMO (VCN-01) is an oncolytic adenovirus, which is a replication competent virus selective of tumoral cells. VCN-01 selectively expresses a matrix-degrading enzyme (hyaluronidase) and its genome contains 4 genetic modifications with respect to the wild-type virus (HAd5) Information relating to the recipient or parental organisms from which the GMO is derived Common Name: HAd5 Genus: Mastadenovirus Species: Human wild-type adenovirus serotype 5 (HAd5) Subspecies: Type-C adenovirus Strain: Pathovar: European Commission administrative Information Consent given by the Member State Competent Authority: Not known
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